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List of Drug Master Files (KDMF) for Gadobutrol Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Bayer AG@Dynamit Nobel GmbH Explosivstoff- und Systemtechnik (1)

02 Dongguk Life Science Co., Ltd. (1)

03 NGChem Life Science Co., Ltd. (1)

04 ST Pharm Co., Ltd. (2)

05 Sionc Pharmaceuticals Pvt. Ltd (1)

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01 Aging Life Science Co., Ltd. (1)

02 Bayer Korea Co., Ltd. (1)

03 Dongguk Life Science Co., Ltd. (1)

04 ENGCHEM Life Science Co., Ltd. (1)

05 ST Pharm Co., Ltd. (2)

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01 Gadobutrol (3)

02 Gadobutrol Monohydrate (1)

03 gadobutrol hydrate (2)

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01 Germany (1)

02 India (1)

03 South Korea (3)

04 Blank (1)

URL Supplier Web Content
Bayer Korea Co., Ltd.
2004-11-05
309-1-ND
Bayer AG@Dynamit Nobel Gm...
Germany
Ernst-Schering-Straße 14...
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Dongguk Life Science Co., Ltd.
2017-08-11
0754-1-ND
Dongguk Life Science Co.,...
South Korea
54-1 Taejanggongdan-gil, ...
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Aging Life Science Co., Ltd.
2020-08-13
Number 434-20-ND
Sionc Pharmaceuticals Pvt...
India
Plot No/ 34A, Road No.1, ...
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ST Pharm Co., Ltd.
2015-09-14
1301-3-ND
ST Pharm Co., Ltd.
South Korea
231 Hyeopjeong-ro, Siheun...
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ST Pharm Co., Ltd.
2018-07-10
1301-7-ND
ST Pharm Co., Ltd.
South Korea
171 Haean-ro, Danwon-gu, ...
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ENGCHEM Life Science Co., Ltd.
2018-05-29
238-6-ND
NGChem Life Science Co., ...
South Korea
59 Bio Valley-ro, Jecheon...
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Looking for / Gadobutrol API manufacturers, exporters & distributors?

Gadobutrol manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Gadobutrol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Gadobutrol manufacturer or Gadobutrol supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gadobutrol manufacturer or Gadobutrol supplier.

PharmaCompass also assists you with knowing the Gadobutrol API Price utilized in the formulation of products. Gadobutrol API Price is not always fixed or binding as the Gadobutrol Price is obtained through a variety of data sources. The Gadobutrol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Gadobutrol

Gadobutrol Manufacturers

A Gadobutrol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gadobutrol, including repackagers and relabelers. The FDA regulates Gadobutrol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gadobutrol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Gadobutrol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Gadobutrol Suppliers

A Gadobutrol supplier is an individual or a company that provides Gadobutrol active pharmaceutical ingredient (API) or Gadobutrol finished formulations upon request. The Gadobutrol suppliers may include Gadobutrol API manufacturers, exporters, distributors and traders.

click here to find a list of Gadobutrol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Gadobutrol KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Gadobutrol Drug Master File in Korea (Gadobutrol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gadobutrol. The MFDS reviews the Gadobutrol KDMF as part of the drug registration process and uses the information provided in the Gadobutrol KDMF to evaluate the safety and efficacy of the drug.

After submitting a Gadobutrol KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Gadobutrol API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Gadobutrol suppliers with KDMF on PharmaCompass.

Gadobutrol Manufacturers | Traders | Suppliers

Gadobutrol Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Gadobutrol

Get in contact with the supplier of your choice:

  1. Bayer AG
  2. Dongkook Lifescience
  3. Sionc Pharmaceuticals
  4. ST Pharma
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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